TOOTH NOTE MOISTURIZING THERAPY TOOTH LEMON BASIL- dental type silica, tocopheryl acetate paste, dentifrice 
GI BILLIONS Co.,Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Dental Type Silica, Tocopheryl Acetate

L-menthol, Glycerin, Other Salts, Lauroyl Amidopropyldi-methylglycine solution, Centella asiatica extract, Potassium Acesulfame, Aloe barbadensis leaf extract, Xylitol, Citrusaurantium dulcis (Orange) oil, Purified water, Calendula officinalis extract, Cellulose gum, Chamomilla recutita (Matricaria) leaf extract, Sodium bicarbonate, Flavor, Sodium hyaluronate

Helps protect against cavities

Keep out of reach of children

Brush the teeth with an appropriate amount of toothpaste.

1) Be careful not to swallow, and rinse mouth thoroughly after use
2) If the use of toothpaste causes abnormalities such as gums or mouth injuries, discontinue use and consult a doctor or dentist
3) If you are a child under 6 years of age, use a small amount of toothpaste as small as pea per use, and use under the supervision of a guardian to avoid sucking or swallowing
4 If a child under 6 years of age swallowed large quantities, consult a physician or dentist immediately
5) Keep out of the reach of children under 6 years

For dental use only

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TOOTH NOTE MOISTURIZING THERAPY TOOTH LEMON BASIL 
dental type silica, tocopheryl acetate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81581-0001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE20 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E)  
WATER (UNII: 059QF0KO0R)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
CENTELLA ASIATICA (UNII: 7M867G6T1U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81581-0001-1150 g in 1 TUBE; Type 0: Not a Combination Product02/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/01/2021
Labeler - GI BILLIONS Co.,Ltd. (695631555)
Registrant - GI BILLIONS Co.,Ltd. (695631555)
Establishment
NameAddressID/FEIBusiness Operations
Biostech Co., Ltd. 687294330manufacture(81581-0001)
Establishment
NameAddressID/FEIBusiness Operations
GI BILLIONS Co.,Ltd. 695631555label(81581-0001)

Revised: 2/2021
Document Id: bbfaec1e-bd75-9445-e053-2a95a90a4861
Set id: bbfae663-9b1c-142f-e053-2995a90a1e1d
Version: 1
Effective Time: 20210223
 
GI BILLIONS Co.,Ltd.